Efficacy Study of Ranibizumab on Patients With Age-related Macular Degeneration.

Macular Degeneration Clinical Trial

— RABIMO  

Official title:

Efficacy of Ranibizumab Treatment Every 2 Month Compared to Treatment on Demand on Patients With Choroidal Neo-vascularization (CNV) as a Consequence of Age-related Macular Degeneration (AMD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01831947
• Other study ID #: CRFB002ADE09T
• Status: Completed
• Phase: Phase 4
• First received: April 11, 2013
• Last updated: April 11, 2013
• Start date: April 2010
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

This clinical trial investigates the impact of intravitreal injection of Ranibizumab antibody on the acuteness of vision. Patients included are suffering from choroidal neo-vascularization (CNV) as a consequence of age-related macular degeneration (AMD).

Initially, all patients get injections of 0.5 mg Ranibizumab in monthly intervals for 3 months. Subsequently, one group gets Ranibizumab in intervals of 2 months, whereas a second group is treated on demand.

The primary end point of the study is the change of best-corrected visual acuity after 12 month.

Secondary end points include the impact of Ranibizumab on morphological changes of the retina, the number of patients with gain or loss of 15 or more letters visual acuity after 12 months, changes in quality of life and the number of injections required during the first 12 months of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• patients with choroidal neo-vascularization (CNV) as a consequence of age-related macular degeneration (AMD)

• age 50 and older, male and female

• membrane <= 12 papillary diameter

• visual acuity between 20/320 and 20/40 (ETDRS)

• written informed consent

Exclusion Criteria:

• known hypersensitivity to the medicinal product under investigation, ingredients or medicinal products with a similar chemical structure

• participation in another clinical trial within the last 4 weeks

• unability to understand trial information

• pregnant or lactating women

• women with an amenorrhea < 12 months

• suspected unability to cooperate

• detachment of pigment epithelium without membrane detection >= 50%,retinal angiomatotic proliferation (RAP), presumed ocular histoplasmosis syndrome (POHS), chorioretinal anastomosis (CRA), myopic CNV, CNV following trauma, uveitis, RCS or reasons except AMD

• rupture of pigment epithelium

• sub-retinal bleeding >= 50% of membrane or >= 1 PD

• sub-retinal fibrosis or chorio-atrophy

• pre-treatment with Verteporfin (photodynamic therapy), radiotherapy, trans-pupillary thermotherapy of the eye under investigation as a consequence of maculadegeneration treatment with Verteporfin of the eye not under investigation within 7 days prior inclusion

• former participation in clinical trials with anti-angiogenic substances: Pegaptanib, Ranibizumab, Bevacizumab, Anecortave Acetat, Proteinkinase C Inhibitors

• former injection of anti-angiogenic substances in the eye under investigation

• former focal sub-foveal lasercoagulation of the eye under investigation

• juxta- or extra-foveal lasercoagulation of the eye under investigation within 1 month prior inclusion

• former vitrectomy

• former surgery as a consequence of maculadegeneration

• glaucoma patients which have been treated with prostaglandin containing eye drops

• other ocular diseases which may lead to surgery within the clinical study or may lead to a loss of vision of two lines

• acute intraocular inflammation of the eye under investigation

• vitreous hemorrhage of the eye under investigation

• macula-foramen of the eye under investigation

• diabetic retinopathy

• former retina detachment of the eye under investigation

• uveitis

• acute conjunctivitis, keratitis, scleritis, or endophthalmitis

• aphakia or pseudo-aphakia with damaged back-capsule(exception: YAG-capsulotomy)

• myopia larger than -8 diopter

• former intra-ocular surgery of the eye under investigation within 2 months prior inclusion

• de-compensated glaucoma with >= 30 mm Hg despite therapy

• former filtrating glaucoma surgery of the eye under investigation

• former corneal grafting of the eye under investigation

• former stroke or heart attack

• on-going therapy because of systemic infection

• known allergic reaction to fluorescein

• bad quality of fundus documentation because of bad range of vision

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Biological:
• Ranibizumab

Locations

Country	Name	City	State
Germany	Dept. of Ophthalmology, University Medical Center Goettingen	Goettingen

Sponsors (3)

Lead Sponsor	Collaborator
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH	Novartis Pharmaceuticals, University Medical Center Goettingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	best-corrected visual acuity	Change of best-corrected visual acuity before and 12 months after start of treatment with respect to number of letters read on ETDRS-sheets (Early Treatment Diabetes Retinopathy Study Sheets).	12 months after start of treatment	No
Secondary	Fluoresceinangiography	To study morphological and anatomical changes of the retina. Affected area is determined in mm²	12 months after start of treatment	No
Secondary	Photography	To study morphological and anatomical changes of the retina. Affected area is assessed by computer-assisted measurement in mm².	12 months after treatment start	No
Secondary	optical coherence tomography (OCT)	To study morphological and anatomical changes of the retina. Thickness of the retina is determined in µm².	12 months after treatment start	No
Secondary	number of injections		12 months after treatment start	No
Secondary	quality of life	change in quality of life	12 months after treatment start	No